Mobile Medical Apps and Product Liability

On Feb. 9, 2015, the agency issued Mobile Medical Applications: Guidance for Food and Drug Administration Staff (the Guidance). At the outset, the FDA acknowledged the nuances between a mobile app and an MMA. It defined a mobile app as a “software application that can be executed or run on a mobile platform, i.e., handheld commercial off-the-shelf computing platform (with or without wireless connectivity) or a Web-based software application that is tailored to a mobile platform but is executed on a server.” The FDA then defined an MMA as a mobile app that meets the definition of “device” in section 201(h) of the Federal Food Drug and Cosmetic Act and is either intended “to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated device.” Under the Act, a medical device is an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article including any component, part or accessory” that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease in man.” The FDA's position is that the intended use of the mobile app determines whether it meets the definition of a medical device. Intended use is shown through labeling claims, advertising materials and written statements by manufacturers or their representatives. Establishing “intended use” depends on the function of the device, not the platform on which it is run.

The FDA's Focus

The focus of the FDA's oversight is only those mobile apps that qualify as MMAs and “whose functionality could pose a risk to a patient's safety if the mobile app were to not function as intended.”

Included in this category are mobile apps that are connected to one or more medical devices and are therefore considered to be an accessory (MMA controlled delivery of insulin through an infusion pump); mobile apps that transform the mobile platform into a regulated medical device (electronic stethoscope); and mobile apps that become regulated medical device software by performing patient-specific analysis, diagnosis or treatment (calculation or creation of dosage plan for radiation therapy).

By contrast, there are mobile apps that may meet the definition of medical device, but pose low risk to patients. For this category of mobile apps, the FDA will exercise its enforcement discretion only, meaning that it does not intend to enforce the requirements of the act. Examples in this category include mobile apps that provide: 1) supplemental clinical care by coaching or prompting patients to help manage their health; 2) tools to organize and track health information; 3) access to information related to a patient's health conditions; 4) tools to help patients document, show or communicate potential medical conditions; and 5) the means to perform simple calculations routinely used in clinical practices.

Finally, there are numerous mobile apps that the FDA does not consider to meet the definition of a medical device, and that the FDA therefore will not regulate. Examples include mobile apps that are intended: 1) to provide access to medical texts or other reference material (medical dictionaries or the PDR); 2) for health-care providers to use as educational tools or medical training (surgical training videos); 3) for general patient education and to facilitate patient access to commonly used reference information (tutorials on how to administer first aid or CPR); 4) to automate general office operations (generate reminders for scheduled medical appointments or blood donation); and 5) as generic aids (magnifying glass not specifically intended for medical purposes).

This discussion concludes in next month's newsletter.

Beth S. Rose is a Member of Sills Cummis & Gross, where she is Chair of the Product Liability Practice Group and a Co-Chair of the Litigation Practice Group. This article also appeared in The Legal Intelligencer, an ALM sister publication of this newsletter.